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临床试验/NCT03021746
NCT03021746已完成不适用

Fostering Sustainability Through Diabetes Self-Management Support

University of Michigan1 个研究点 分布在 1 个国家目标入组 358 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
358
试验地点
1
主要终点
Change in A1C Blood Glucose level

研究概览

简要总结

To understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings.

详细描述

To understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Have Type 2 diabetes for at least 6 months
  • •Be Black/African American
  • •Be a resident of metro-Detroit, Toledo, or Flint
  • •Be at least 21 years old
  • •Be under the care of a physician for diabetes
  • •Have transportation to attend the program

排除标准

  • •Have Type 2 diabetes for less than 6 months
  • •Under 21 years of age
  • •Not under care of physician
  • •Lack of transportation to attend the program

研究组 & 干预措施

Parish Nurse plus Peer Leader

Experimental

The focus of this approach is for Peer Leaders (PL) to provide Diabetes Self Management Support (DSMS) with the oversight of Parish Nurses (PN). The first component starts with group-based Diabetes Self Management Education (DSME) provided by Certified Diabetes Educators (CDE), co-facilitated by PN and PL and held at the church. PL will also facilitate activities including behavioral goal setting, monthly phone contacts, and preparation for a diabetes-related health care visit, with oversight of PN. As the study progresses, PL and PN will have progressive leadership responsibilities. Following DSME, participants will be invited to attend 12 months of monthly DSMS support groups led by the PL, with oversight from the PN. This approach allows for PN to provide direct supervision to PL in areas of clinical content, educational methods, and group facilitation and communication skills.

干预措施: Diabetes Self Management Support (DSMS) (Behavioral)

Peer Leader Only

Experimental

This approach will contain the same elements as the PN plus PL approach, except that a PN will not be used. Rather, PL will provide all aspects of DSMS, including behavioral goal setting, monthly phone contacts, and preparation for a diabetes-related health care visit. This approach will be delivered in a group setting. DSME will be provided by CDEs and co-facilitated by a PL to ensure consistency in the DSME content. Following DSME, participants will be invited to attend 12 monthly DSMS groups led by PL. Following the group sessions, participants will transition into a period of ongoing support. During this time, participants and PL will be encouraged to foster DSMS through programs and initiatives that are meaningful to them, utilizing the existing church infrastructure. If needed, PL may contact the CDE for additional information

干预措施: Diabetes Self Management Support (DSMS) (Behavioral)

Parish Nurse Only

Experimental

The main focus of this approach will contain all of the same elements as the PN plus PL approach, except that PL will not be used. Rather, the PN will provide all aspects of Diabetes Self Management Support (DSMS), including facilitation of goal setting, monthly phone contacts, and preparation for a diabetes-related health care visit. Diabetes Self Management Education (DSME) will be provided by CDEs and co-facilitated by a PN to ensure consistency in the DSME content. Following DSME, participants will be invited to attend 12 months of monthly, DSMS support groups led by the PN. Following support sessions, participants will transition into a period of ongoing support, where the participants and PN will be encouraged to continue to foster DSMS through programs and initiatives that are meaningful to them, utilizing the existing church infrastructure. The PN may answer clinical questions and may contact the CDE for additional information if needed.

干预措施: Diabetes Self Management Support (DSMS) (Behavioral)

结局指标

主要结局

Change in A1C Blood Glucose level

时间窗: During this study, A1c will be measured at five time points; baseline, 6 months, 9 months, 21 months, and 33 months.

An A1C test is a blood test that reflects one's average blood glucose levels over the previous 3 months.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gretchen Piatt

Assistant Professor

University of Michigan

研究点 (1)

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